NCT03479619已完成不适用
Comparison of Three Lancing Devices Regarding Capillary Blood Volume and Lancing Pain Intensity.
HTL-Strefa S.A.2 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2018年3月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Volume (uL) of blood in the capillary tube
研究概览
简要总结
A randomized single-blind study with the use of three lancing devices equipped with personal lancets. Every device will be studied for three lancet sizes: 28G, 30G, and 33G with the minimum and maximum puncture depth setting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with diagnosed diabetes type 1 or 2 ,
- •aged 18 - 50,
- •period of suffering from diabetes >2 years,
- •performing on average 3-8 daily measurements of glycaemia,
- •glycaemia at the moment of the beginning of the study between 70 and 200 mg/dl.
排除标准
- •glycaemia below 70 mg/dl or glycaemia above 200 mg/dl at the moment of the beginning of the study,
- •previously diagnosed hemorrhagic diathesis or heavy bleedings in the past (also those without a medical diagnosis),
- •anticoagulant (thrombolytic medication) therapy within 3 weeks prior to the study or on the day of the study,
- •non steroidal anti-inflammatory drugs (NSAID) treatment 1 week prior to the study or on the day of the study,
- •patients with signs of dehydration,
- •patients who are currently participating in another clinical study,
- •currently diagnosed or reported by the patient skin diseases, nervous system diseases, psychiatric diseases, etc., which, in the opinion of the person conducting the study, disqualify the patient from the participation in the study, in care for the patient's well-being.
结局指标
主要结局
Volume (uL) of blood in the capillary tube
时间窗: 1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min
Examination of the volume of blood obtained after puncturing a fingertip with the use of 3 lancing devices set to minimum and maximum puncture depth, with the use of various-sized personal lancets (28G, 30G, and 33G). The volume of blood sample will be measured with the use of capillary tubes calibrated for the volume of 10 μl and a graduated ruler.
次要结局
- The intensity of pain perceived by the patient assessed with the use of the VAS (Visual Analog Scale).(1 - 3.5 hours (on average 2.5 hours) plus observation time after study 30 min)
研究者
研究点 (2)
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